Reductions in Mean 24-Hour Ambulatory Blood Pressure After 6-Week Treatment With Canagliflozin in Patients With Type 2 Diabetes Mellitus and Hypertension

Abstract

This randomized, double-blind, placebo-controlled study evaluated the early effects of canagliflozin on blood pressure (BP) in patients with type 2 diabetes mellitus (T2DM) and hypertension. Patients were randomized to canagliflozin 300 mg, canagliflozin 100 mg, or placebo for 6 weeks and underwent 24-hour ambulatory BP monitoring before randomization, on day 1 of treatment, and after 6 weeks. The primary endpoint was change in mean 24-hour systolic BP (SBP) from baseline to week 6. Overall, 169 patients were included (mean age, 58.6 years; glycated hemoglobin, 8.1%; seated BP 138.5/82.7 mm Hg). At week 6, canagliflozin 300 mg provided greater reductions in mean 24-hour SBP than placebo (least squares mean -6.2 vs -1.2 mm Hg, respectively; P=.006). Numerical reductions in SBP were observed with canagliflozin 100 mg. Canagliflozin was generally well tolerated, with side effects similar to those reported in previous studies. These results suggest that canagliflozin rapidly reduces BP in patients with T2DM and hypertension.

Figure 1

Study design. ABPM indicates ambulatory blood pressure monitoring; QD, once daily. ^aOne to three antihyperglycemic agents (metformin with or without sulphonyureas, thiazolidinediones, or dipeptidyl peptidase‐4 inhibitors). ^bOne to three antihypertensive agents (angiotensin‐converting enzyme inhibitor or angiotensin receptor blocker with or without diuretics [other than loop diuretics], calcium channel blockers, or β‐blockers).

Figure 2

Patient disposition.

Figure 3

Hourly mean 24‐hour ambulatory blood pressure (BP) monitoring (ABPM) systolic BP (SBP) and diastolic BP (DBP) for canagliflozin (CANA) 300 mg, 100 mg, and placebo at baseline, day 2, and week 6 (last observation carried forward). The x axis indicates the hourly time after the morning dose of the study medication. SE indicates standard error.